Ophthalmic Knife and Methods of Use

ABSTRACT

The present invention relates to an ophthalmic knife and methods of its use for treatment of various conditions including eye diseases, such as glaucoma, using minimally invasive surgical techniques. The invention relates to a multi-blade device for cutting the tissues within the eye, for example, a trabecular meshwork (TM).

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/389,328, filed Dec. 22, 2016, which is a nonprovisional patentapplication of and claims the benefit to U.S. Provisional PatentApplication No. 62/387,351, filed Dec. 23, 2015 and titled “Ophthalmicknife and methods of use.”

FIELD OF THE INVENTION

The present invention relates to an ophthalmic knife and methods of itsuse for treatment of various conditions including eye diseases, such asglaucoma, using minimally invasive surgical techniques. An ophthalmicknife can be used for cutting the tissues within the eye, for example, atrabecular meshwork (TM). This invention also relates to surgicalmedicinal intervention. For example, the present invention relates to amicrosurgical device and methods of its use for treatment of variousmedical conditions including but not limited to eye diseases, such asglaucoma, using minimally invasive surgical techniques.

BACKGROUND OF THE INVENTION

There are numerous medical and surgical procedures in which it isdesirable to cut and remove a strip of tissue of controlled width fromthe body of a human or veterinary patient. For example, it may sometimesbe desirable to form an incision of a controlled width (e.g., anincision that is wider than an incision made by a typical scalpel,cutting blade or needle) in the eye, skin, mucous membrane, tumor, organor other tissue or a human or animal. In addition, it may sometimes bedesirable to remove a strip or quantity of tissue from the body of ahuman or animal for use as a biopsy specimen, for chemical/biologicalanalysis, for retention or archival of DNA identification purposes, etc.In addition, some surgical procedures require removal of a strip oftissue of a known width from an anatomical location within the body of apatient. One surgical procedure wherein a strip of tissue of a knownwidth is removed from an anatomical location within the body of apatient is an ophthalmological procedure used to treat glaucoma. Thisophthalmological procedure is sometimes referred to as a goniotomy. In agonioctomy procedure, a device that is operative to cut or ablate astrip of tissue of approximately 2-10 mm in length or more and about50-200 μm in width is inserted into the anterior chamber of the eye andused to remove a full thickness strip of tissue from the trabecularmeshwork. At present there remains a need in the art for the developmentof simple, inexpensive and accurate instruments useable to perform theprocedure of cutting the trabecular meshwork (TM) in the eye andeffectively remove a complete full thickness strip of TM without leavingTM leaflets as well as other procedures where it is desired to remove astrip of tissue from a larger mass of tissue.

SUMMARY OF THE INVENTION

The present invention relates to an ophthalmic knife and methods of itsuse for treatment of various conditions including eye diseases, such asglaucoma, using minimally invasive surgical techniques. An ophthalmicknife can be used for cutting the tissues within the eye, for example, atrabecular meshwork (TM). This invention also relates to surgicalmedicinal intervention. For example, the present invention relates to amicrosurgical device and methods of its use for treatment of variousmedical conditions including but not limited to eye diseases, such asglaucoma, using minimally invasive surgical techniques.

In one embodiment, the present invention contemplates a dualplatform/dual-blade ophthalmic knife comprising a handle connected to ashaft, said shaft connected to a first platform and a second platform,said first platform comprising a first and second blade and a firstanterior blade tip and said second platform comprising a third andfourth blade and a second anterior blade tip. In one embodiment, theanterior blade tip is a retractable blade tip. In one embodiment, saidfirst and second anterior blade tips are retractable blade tips. In oneembodiment, the anterior blade tip is a wedge blade tip. In oneembodiment, the first blade and a second blade are attached to a firstlateral side and a second lateral side (respectively) of the firstplatform. In one embodiment, the third blade and a fourth blade areattached to a third lateral side and a fourth lateral side(respectively) of the second platform. In one embodiment, the firstplatform and second platform are configured at a 180° angle. In oneembodiment, said blade tips comprise right triangles. In one embodiment,said right triangle follows the Pythagoras' theorem formula (a²+b²=c²)wherein the sides of said tip comprise length a and b and the length ofthe hypotenuse is c. 8. In one embodiment, said platforms each comprisesa ramp. In one embodiment, said distal end of said platform ramps upfrom the piercing blade towards to parallel blades. In one embodiment,said distal end of said platform ramps up from the piercing bladetowards to parallel blades that are positioned above the level of theTM. In one embodiment, the first and second platform are offset. In oneembodiment, the first platform and second platform are parallel. In oneembodiment, the first platform comprises a first ramp increasing indepth extending from the first anterior blade tip to a first posteriorend. In one embodiment, the second platform comprises a second rampincreasing in depth extending from the second anterior blade tip to asecond posterior end. In one embodiment, the first and second blades areparallel. In one embodiment, the first and second blade are at an angle.In one embodiment, the platform comprises an annular cutting edge. Inone embodiment, the third and fourth blades are parallel. In oneembodiment, the third and fourth blades are at an angle. In oneembodiment, the first platform comprises an annular cutting edge. In oneembodiment, the second platform comprises an annular cutting edge. Inone embodiment, the first and second lateral blades are retractable andattached within a first and second platform cavity (respectively). Inone embodiment, the third and fourth lateral blades are retractable andattached within a third and fourth platform cavity (respectively). Inone embodiment, the handle comprises a lateral blade actuator switch inoperable communication with the first, second, third and fourth platformcavities. In one embodiment, the platform further comprises a graspingfeature. In one embodiment, said parallel dual platforms can be actuatedto come together to grasp tissue. In one embodiment, the graspingfeature includes but is not limited to, a tweezer element or a forcepelement. In one embodiment, parallel dual platforms can be actuated tocome together to grasp tissue. In one embodiment, the grasping featurecomprises a sleeve extending over the shaft, wherein the handlecomprises a sleeve actuator switch. In one embodiment, the graspingfeature is made of a shape-memory material that is retractable into alumen of the device. In one embodiment, the platform further comprises aslidable punch that can detach tissue from the multi-blade device. Inone embodiment, the multi-blade device further comprises at least onelumen extending longitudinally within said handle, shaft and platform.In one embodiment, the lumen comprises an exit port in said platform. Inone embodiment, the exit port is on the top surface of the platform. Inone embodiment, the exit port is on the bottom surface of the platform.In one embodiment, the lumen comprises an entry port in said handle. Inone embodiment, the lumen comprises a viscoelastic fluid. In oneembodiment, the lumen comprises an aspiration fluid. In one embodiment,the platform further comprises a through-hole extending from the topsurface to the posterior end. In one embodiment, the handle is curved.In one embodiment, the device further comprises a fiber opticvisualization system. In one embodiment, the width of the platform isapproximately 150-180 microns. In one embodiment, the platform is acolor including, but not limited to, blue, white, black, orange andyellow or any combination thereof. In one embodiment, the platformcomprises a concave bottom surface. In one embodiment, the shaftcomprises an annular ring. In one embodiment, the platform furthercomprises at least one heating element. In one embodiment, the shaft isa telescoping shaft.

In one embodiment, the present invention contemplates a quad-bladeophthalmic knife comprising a handle connected to a shaft, said shaftconnected to a platform comprising four cutting blades and an anteriorblade tip. In one embodiment, the anterior blade tip is a retractableblade tip. In one embodiment, the anterior blade tip is a wedge bladetip. In one embodiment, the platform comprises a first blade and asecond blade attached to a first lateral side and a second lateral side(respectively) of the platform. In one embodiment, said blade tipcomprises a right triangle. In one embodiment, said right trianglefollows the Pythagoras' theorem formula (a²+b²=c²) wherein the sides ofsaid tip comprise length a and b and the length of the hypotenuse is c.In one embodiment, said platform comprises a ramp. In one embodiment,said distal end of said platform ramps up from the piercing bladetowards to parallel blades. In one embodiment, said distal end of saidplatform ramps up from the piercing blade towards to parallel bladesthat are positioned above the level of the TM. In one embodiment, theshaft further comprises a third blade and a fourth blade attached to afirst lateral side and a second lateral side (respectively) of theshaft. In one embodiment, the third and fourth blade are slidablyengaged with the shaft. In one embodiment, the handle comprises acompressible material that contacts said third and fourth blades. In oneembodiment, the shaft is connected to a second quad-blade knifepositioned at a 180° angle from the first quad-blade knife. In oneembodiment, the shaft is connected to a second quad-blade knife positionin parallel to the first quad-blade knife. In one embodiment, theplatform comprises a ramp increasing in depth extending from theanterior blade tip to the posterior end. In one embodiment, the firstand second blades are parallel. In one embodiment, the first and secondblade are at an angle. In one embodiment, the platform comprises anannular cutting edge. In one embodiment, the first and second lateralblades are retractable and attached within a first and second platformcavity (respectively). In one embodiment, the handle comprises a lateralblade actuator switch in operable communication with the first andsecond platform cavities. In one embodiment, the platform furthercomprises a grasping feature. In one embodiment, the grasping featureincludes but is not limited to, a tweezer element or a forcep element.In one embodiment, the grasping feature comprises a sleeve extendingover the shaft, wherein the handle comprises a sleeve actuator switch.In one embodiment, the platform further comprises a slidable punch thatcan detach tissue from the multi-blade device. In one embodiment, themulti-blade device further comprises at least one lumen extendinglongitudinally within said handle, shaft and platform. In oneembodiment, the lumen comprises an exit port in said platform. In oneembodiment, the exit port is on the top surface of the platform. In oneembodiment, the exit port is on the bottom surface of the platform. Inone embodiment, the lumen comprises an entry port in said handle. In oneembodiment, the lumen comprises a viscoelastic fluid. In one embodiment,the lumen comprises an aspiration fluid. In one embodiment, the platformfurther comprises a through-hole extending from the top surface to theposterior end. In one embodiment, the handle is curved. In oneembodiment, the device further comprises a fiber optic visualizationsystem. In one embodiment, the width of the platform is approximately150-180 microns. In one embodiment, the platform is a color including,but not limited to, blue, white, black, orange and yellow or anycombination thereof. In one embodiment, the platform comprises a concavebottom surface. In one embodiment, the shaft comprises an annular ring.In one embodiment, the platform further comprises at least one heatingelement. In one embodiment, the shaft is a telescoping shaft.

In one embodiment, the present invention contemplates an ultrasonicophthalmic knife comprises a handle, shaft, an anterior blade tip, andplatform wherein the platform comprises an ultrasonic emitter and afootplate protecting surrounding tissue from the ultrasonic blades. Inone embodiment, the ultrasonic emitter anterior blade tip vibrates in afixed frequency when the device is actuated. In one embodiment, bothlongitudinal and lateral motions are possible for the tip. In oneembodiment, said ultrasonic emitter has adjustable power settings. Inone embodiment, said power settings are optimized to minimize theapplication of heat during use. The ultrasonic knife allows for tissuecutting while reducing the need to pre-stretch or tension tissue. Theknife tip vibrates in a fixed frequency when the device is actuated.Both longitudinal and lateral motions are possible for the tip. Powersettings are optimized to minimize the application of heat to thetissue. In one embodiment, the anterior blade tip is a wedge blade tip.In one embodiment, the anterior blade tip is a retractable blade tip. Inone embodiment, said blade tip comprises a right triangle. In oneembodiment, said right triangle follows the Pythagoras' theorem formula(a²+b²=c²) wherein the sides of said tip comprise length a and b and thelength of the hypotenuse is c. In one embodiment, said platformcomprises a ramp. In one embodiment, said distal end of said platformramps up from the piercing blade towards to parallel blades. In oneembodiment, said distal end of said platform ramps up from the piercingblade towards to parallel blades that are positioned above the level ofthe TM. In one embodiment, the platform further comprises a graspingfeature. In one embodiment, the grasping feature includes but is notlimited to, a tweezer element or a forcep element. In one embodiment,the grasping feature comprises a sleeve extending over the shaft,wherein the handle comprises a sleeve actuator switch. In oneembodiment, the platform further comprises a slidable punch that candetach tissue from the ultrasonic knife. In one embodiment, theultrasonic device further comprises at least one lumen extendinglongitudinally within said handle, shaft and platform. In oneembodiment, the lumen comprises an exit port in said platform. In oneembodiment, the exit port is on the top surface of the platform. In oneembodiment, the exit port is on the bottom surface of the platform. Inone embodiment, the lumen comprises an entry port in said handle. In oneembodiment, the lumen comprises a viscoelastic fluid. In one embodiment,the lumen comprises an aspiration fluid. In one embodiment, the platformfurther comprises a through-hole extending from the top surface to theposterior end. In one embodiment, the handle is curved. In oneembodiment, the ultrasonic device further comprises a fiber opticvisualization system. In one embodiment, the width of the platform isapproximately 150-180 microns. In one embodiment, the platform is acolor including, but not limited to, blue, white, black, orange andyellow or any combination thereof. In one embodiment, the platformcomprises a concave bottom surface. In one embodiment, the shaftcomprises an annular ring. In one embodiment, the platform furthercomprises at least one heating element. In one embodiment, the shaft isa telescoping shaft.

In one embodiment, the present invention contemplates a pincerophthalmic knife comprising a handle connected to a shaft, said shaftconnected to a lower platform and an upper platform. In one embodiment,the lower platform comprises an anterior blade tip. In one embodiment,the anterior blade tip is a wedge blade tip. In one embodiment, theshaft and the upper platform are connected by a hinge. In oneembodiment, the lower platform comprises a first lateral side attachedto a first blade and a second lateral side attached to a second blade.In one embodiment, the upper platform comprises a first slot and asecond slot, wherein the first and second slots are positioned abovesaid first and second blades. In one embodiment, the lower platformfurther comprises an anterior blade tip. In one embodiment, said bladetip comprises a right triangle. In one embodiment, said right trianglefollows the Pythagoras' theorem formula (a²+b²=c²) wherein the sides ofsaid tip comprise length a and b and the length of the hypotenuse is c.In one embodiment, said platform comprises a ramp. In one embodiment,said distal end of said platform ramps up from the piercing bladetowards to parallel blades. In one embodiment, said distal end of saidplatform ramps up from the piercing blade towards to parallel bladesthat are positioned above the level of the TM. In one embodiment, thelower platform is at least 8 mm in length. In one embodiment, theplatform further comprises a grasping feature. In one embodiment, thegrasping feature includes but is not limited to, a tweezer element or aforcep element. In one embodiment, the grasping feature comprises asleeve extending over the shaft, wherein the handle comprises a sleeveactuator switch. In one embodiment, the platform further comprises aslidable punch that can detach tissue from the pincer ophthalmic knife.In one embodiment, the pincer ophthalmic knife device further comprisesat least one lumen extending longitudinally within said handle, shaftand platform. In one embodiment, the lumen comprises an exit port insaid platform. In one embodiment, the exit port is on the top surface ofthe platform. In one embodiment, the exit port is on the bottom surfaceof the platform. In one embodiment, the lumen comprises an entry port insaid handle. In one embodiment, the lumen comprises a viscoelasticfluid. In one embodiment, the lumen comprises an aspiration fluid. Inone embodiment, the platform further comprises a through-hole extendingfrom the top surface to the posterior end. In one embodiment, the handleis curved. In one embodiment, the pincer ophthalmic knife device furthercomprises a fiber optic visualization system. In one embodiment, thewidth of the platform is approximately 150-180 microns. In oneembodiment, the platform is a color including, but not limited to, blue,white, black, orange and yellow or any combination thereof. In oneembodiment, the platform comprises a concave bottom surface. In oneembodiment, the shaft comprises an annular ring. In one embodiment, theplatform further comprises at least one heating element. In oneembodiment, the shaft is a telescoping shaft.

In one embodiment, the present invention contemplates a grippingophthalmic knife comprising a handle connected to a shaft, said shaftcomprises an first lateral alligator clip and a second lateral alligatorclip, a platform connected to the shaft, said platform comprising afirst lateral blade and a second lateral blade, and an anterior bladetip. In one embodiment, the anterior blade tip is a wedge blade tip. Inone embodiment, the anterior blade tip is a retractable blade tip. Inone embodiment, said blade tip comprises a right triangle. In oneembodiment, said right triangle follows the Pythagoras' theorem formula(a²+b²=c²) wherein the sides of said tip comprise length a and b and thelength of the hypotenuse is c. In one embodiment, said platformcomprises a ramp. In one embodiment, said distal end of said platformramps up from the piercing blade towards to parallel blades. In oneembodiment, said distal end of said platform ramps up from the piercingblade towards to parallel blades that are positioned above the level ofthe TM. In one embodiment, the first lateral blade and the secondlateral blade are attached to a first lateral side and a second lateralside (respectively) of the platform. In one embodiment, the firstlateral alligator clip comprises a first serrated jaw and a secondserrated jaw. In one embodiment, the second lateral alligator clipcomprises a first serrated jaw and a second serrated jaw. In oneembodiment, the first and second serrated jaws of the first lateralalligator clip are hinged. In one embodiment, the first and secondserrated jaws of the second lateral alligator clip are hinged. In oneembodiment, the handle comprises a compressible material that contactssaid first and second alligator clips. In one embodiment, the platformfurther comprises a grasping feature. In one embodiment, the graspingfeature includes but is not limited to, a tweezer element or a forcepelement. In one embodiment, the grasping feature comprises a sleeveextending over the shaft, wherein the handle comprises a sleeve actuatorswitch. In one embodiment, the platform further comprises a slidablepunch that can detach tissue from the multi-blade device. In oneembodiment, the multi-blade device further comprises at least one lumenextending longitudinally within said handle, shaft and platform. In oneembodiment, the lumen comprises an exit port in said platform. In oneembodiment, the exit port is on the top surface of the platform. In oneembodiment, the exit port is on the bottom surface of the platform. Inone embodiment, the lumen comprises an entry port in said handle. In oneembodiment, the lumen comprises a viscoelastic fluid. In one embodiment,the lumen comprises an aspiration fluid. In one embodiment, the platformfurther comprises a through-hole extending from the top surface to theposterior end. In one embodiment, the handle is curved. In oneembodiment, the device further comprises a fiber optic visualizationsystem. In one embodiment, the width of the platform is approximately150-180 microns. In one embodiment, the platform is a color including,but not limited to, blue, white, black, orange and yellow or anycombination thereof. In one embodiment, the platform comprises a concavebottom surface. In one embodiment, the shaft comprises an annular ring.In one embodiment, the platform further comprises at least one heatingelement. In one embodiment, the shaft is a telescoping shaft.

In one embodiment, the present embodiment contemplates a lancetophthalmic knife comprising a handle connected to a shaft, said shaftconnected to a wire element. In one embodiment, the wire elementcomprises a geometric shape including, but not limited to, a triangle,square, a rectangular, an octagon, a circle, an ellipse or an oval. Inone embodiment, the wire element comprises a first wire end and secondwire end. In one embodiment, the first wire end is connected to theshaft at a first position. In one embodiment, the second wire end isconnected to the shaft at a second position. In one embodiment, theshaft further comprises a grasping feature. In one embodiment, thegrasping feature includes but is not limited to, a tweezer element or aforcep element. In one embodiment, the grasping feature comprises asleeve extending over the shaft, wherein the handle comprises a sleeveactuator switch. In one embodiment, the shaft further comprises aslidable punch that can detach tissue from the wire element. In oneembodiment, the lancet knife further comprises at least one lumenextending longitudinally within said handle and shaft. In oneembodiment, the lumen comprises an exit port in said shaft. In oneembodiment, the lumen comprises an entry port in said handle. In oneembodiment, the lumen comprises a viscoelastic fluid. In one embodiment,the lumen comprises an aspiration fluid. In one embodiment, the handleis curved. In one embodiment, the device further comprises a fiber opticvisualization system. In one embodiment, the wire element is a colorincluding, but not limited to, blue, white, black, orange and yellow orany combination thereof. In one embodiment, the shaft comprises anannular ring. In one embodiment, the wire element further comprises atleast one heating element. In one embodiment, the shaft is a telescopingshaft.

In one embodiment, the present invention contemplates an axial bladeophthalmic knife comprising a handle connected to a shaft, said shaftconnected to a first and second blade. In one embodiment, the first andsecond blade extend axially from the shaft. In one embodiment, a shaftoverhang is positioned between the first and second blades and thelateral edges of the shaft. The overhang is positioned so as to limitthe depth of cut made by the blades. In one embodiment, the shaftfurther comprises a grasping feature. In one embodiment, the graspingfeature includes but is not limited to, a tweezer element or a forcepelement. In one embodiment, the grasping feature comprises a sleeveextending over the shaft, wherein the handle comprises a sleeve actuatorswitch. In one embodiment, the shaft further comprises a slidable punchthat can detach tissue from the shaft. In one embodiment, the ophthalmicknife further comprises at least one lumen extending longitudinallywithin said handle and shaft. In one embodiment, the lumen comprises anexit port in said shaft. In one embodiment, the lumen comprises an entryport in said handle. In one embodiment, the lumen comprises aviscoelastic fluid. In one embodiment, the lumen comprises an aspirationfluid. In one embodiment, the handle is curved. In one embodiment, thedevice further comprises a fiber optic visualization system. In oneembodiment, the shaft is a color including, but not limited to, blue,white, black, orange and yellow or any combination thereof. In oneembodiment, the shaft comprises an annular ring. In one embodiment, thefirst and second blades further comprise at least one heating element.In one embodiment, the shaft is a telescoping shaft.

In one embodiment, the present invention contemplates a V-bladeophthalmic knife comprising a handle connected to a shaft comprising afirst blade, said shaft connected to a platform, wherein the first bladeoverhangs said platform such that the first blade and said platform areconnected at an angle. In one embodiment, the platform further comprisesan anterior blade tip. In one embodiment, the anterior blade tip is aretractable blade tip. In one embodiment, the anterior blade tip is awedge blade tip. In one embodiment, said blade tip comprises a righttriangle. In one embodiment, said right triangle follows the Pythagoras'theorem formula (a²+b²=c²) wherein the sides of said tip comprise lengtha and b and the length of the hypotenuse is c. In one embodiment, saidplatform comprises a ramp. In one embodiment, said distal end of saidplatform ramps up from the piercing blade towards to parallel blades. Inone embodiment, said distal end of said platform ramps up from thepiercing blade towards to parallel blades that are positioned above thelevel of the TM. In one embodiment, the platform comprises a rampincreasing in depth extending from the anterior blade tip to theposterior end. In one embodiment, the platform comprises a rampincreasing in depth extending from the anterior blade tip to theposterior end. In one embodiment, the platform comprises an annularcutting edge. In one embodiment, the shaft further comprises a graspingfeature. In one embodiment, the grasping feature includes but is notlimited to, a tweezer element or a forcep element. In one embodiment,the grasping feature comprises a sleeve extending over the shaft,wherein the handle comprises a sleeve actuator switch. In oneembodiment, the shaft further comprises a slidable punch that can detachtissue from the shaft. In one embodiment, the ophthalmic knife furthercomprises at least one lumen extending longitudinally within said handleand shaft. In one embodiment, the lumen comprises an exit port in saidshaft. In one embodiment, the lumen comprises an entry port in saidhandle. In one embodiment, the lumen comprises a viscoelastic fluid. Inone embodiment, the lumen comprises an aspiration fluid. In oneembodiment, the handle is curved. In one embodiment, the device furthercomprises a fiber optic visualization system. In one embodiment, theshaft is a color including, but not limited to, blue, white, black,orange and yellow or any combination thereof. In one embodiment, theshaft comprises an annular ring. In one embodiment, the first and secondblades further comprise at least one heating element. In one embodiment,the shaft is a telescoping shaft.

In one embodiment, the present invention contemplates, a method forusing an ophthalmic knife, comprising: a) providing an ophthalmic knifeselected from the group consisting of a dual platform/dual bladeophthalmic knife, a quad-blade ophthalmic knife, an ultrasonicophthalmic knife, a pincer ophthalmic knife, a gripping ophthalmicknife, a lancet ophthalmic knife, an axial blade ophthalmic knife and aV-blade ophthalmic knife; b) advancing said ophthalmic knife through anincision to a tissue target site; and c) cutting a strip of tissue fromsaid target site. In one embodiment, the knife is integrated into anendoscope. In one embodiment, the method further comprises visualizingsaid cutting with a fiber optic visualization system. In one embodiment,the tissue target site is located within the body of a patient. In oneembodiment, the method further comprises the step of removing said stripof tissue from said tissue target site. In one embodiment, the methodfurther comprises the step of treating said patient for glaucoma. In oneembodiment, the treating comprises draining aqueous humor from the eyeof said subject. In one embodiment, said advancing further comprises; i)inserting said knife into an ocular anterior chamber; and ii)positioning said knife adjacent to, or within, a trabecular meshwork ofthe eye. In one embodiment, said incision is in an anatomical locationselected from the group consisting of an eyeball, skin, mucous membrane,an organ, and a tumor.

Definitions

To facilitate the understanding of this invention, a number of terms aredefined below. Terms defined herein have meanings as commonly understoodby a person of ordinary skill in the areas relevant to the presentinvention. Terms such as “a”, “an” and “the” are not intended to referto only a singular entity, but include the general class of which aspecific example may be used for illustration. The terminology herein isused to describe specific embodiments of the invention, but their usagedoes not delimit the invention, except as outlined in the claims. Asused herein, the term “patient” or “subject” refers to a livingmammalian organism, such as a human, monkey, cow, sheep, goat, dog, cat,mouse, rat, guinea pig, or transgenic species thereof. In certainembodiments, the patient or subject is a primate. Non-limiting examplesof human subjects are adults, juveniles, infants and fetuses.

The inventive subject matter disclosed herein is not to be restrictedexcept in the spirit of the disclosure. Moreover, in interpreting thedisclosure, all terms should be interpreted in the broadest possiblemanner consistent with the context. In particular, the terms “comprises”and “comprising” should be interpreted as referring to elements,components, or steps in a non-exclusive manner, indicating that thereferenced elements, components, or steps may be present, or utilized,or combined with other elements, components, or steps that are notexpressly referenced.

“Prevention” or “preventing” includes: (1) inhibiting the onset of adisease in a subject or patient which may be at risk and/or predisposedto the disease but does not yet experience or display any or all of thepathology or symptomatology of the disease, and/or (2) slowing the onsetof the pathology or symptomatology of a disease in a subject or patientwhich may be at risk and/or predisposed to the disease but does not yetexperience or display any or all of the pathology or symptomatology ofthe disease.

The term “therapeutically effective amounts” or “pharmaceuticallyeffective amounts”, as used herein means that amount which, whenadministered to a subject or patient for treating a disease, issufficient to effect such treatment for the disease or to ameliorate oneor more symptoms of a disease or condition (e.g. ameliorate pain).

As used herein, the terms “treat” and “treating” are not limited to thecase where the subject (e.g. patient) is cured and the disease iseradicated. Rather, the present invention also contemplates treatmentthat merely reduces symptoms, improves (to some degree) and/or delaysdisease progression. It is not intended that the present invention belimited to instances wherein a disease or affliction is cured. It issufficient that symptoms are reduced.

As used herein “goniotomy” refers to a surgical procedure primarily usedto treat congenital glaucoma or other types of glaucoma.

As used herein “trabecular meshwork” refers to area of tissue in the eyelocated around the base of the cornea, near the ciliary body, (betweenthe scleral spur and schwalbe's line) and is responsible for drainingthe aqueous humor from the eye via the anterior chamber (the chamber onthe front of the eye covered by the cornea). The tissue is spongy andlined by trabeculocytes; it allows fluid to drain into a set of tubescalled Schlemm's canal and eventually flowing into the blood system.

As used herein “Schlemm's canal” refers to a circular channel in the eyethat collects aqueous humor from the anterior chamber and delivers itinto the bloodstream via the collector channels and anterior ciliaryveins.

As used herein “eye diseases” refers to various conditions of the eyeincluding, but not limited to Glaucoma—optic neuropathy, Glaucomasuspect—ocular hypertension, Primary open-angle glaucoma, Primaryangle-closure glaucoma, primary open angle glaucoma, normal or lowtension glaucoma, pseudoexfoliation glaucoma, pigment dispersionglaucoma, angle closure glaucoma (acute, subacute, chronic), neovascularor inflammatory glaucoma, ocular hypertension, and other types ofglaucoma that are related to dysregulation of intraocular pressure

As used herein “hypotony” refers to reduced intraocular pressure. Thestatistical definition of hypotony is intraocular pressure (IOP) lessthan 6.5 mmHg, which is more than 3 standard deviations below the meanTOP. The clinical definition of hypotony is TOP low enough to result inpathology (vision loss). The vision loss from low TOP may be caused bycorneal edema, astigmatism, cystoid macular edema, maculopathy, or othercondition. Hypotony maculopathy is characterized by a low TOP associatedwith fundus abnormalities, including chorioretinal folds, optic nervehead edema in the acute setting, and vascular tortuosity.

As used herein “Schwalbe's line” refers to the anatomical line found onthe interior surface of the eye's cornea, and delineates the outer limitof the corneal endothelium layer. Specifically, it represents thetermination of Descemet's membrane.

As used herein “descemet's membrane” refers to the basement membranethat lies between the corneal proper substance, also called stroma, andthe endothelial layer of the cornea.

As used herein “scleral spur” refers to an annular structure composed ofcollagen in the human eye, a protrusion of the sclera into the anteriorchamber. It is the origin of the longitudinal fibres of the ciliarymuscle and is attached anteriorly to the trabecular meshwork. Open-angleglaucoma (OAG) and closed-angle glaucoma (CAG) may be treated bymuscarinic receptor agonists (e.g., pilocarpine), which cause rapidmiosis and contraction of the ciliary muscles, this pulls the scleralspur and results in the trabecular meshwork being stretched andseparated. This opens the fluid pathways and facilitates drainage of theaqueous humour into the canal of Schlemm and ultimately decreasingintraocular pressure.

As used herein “Trabectome®” refers to a minimally invasive glaucomasurgical tool for the surgical management of adult, juvenile andinfantile glaucoma. Unlike a trabeculectomy, the surgery with aTrabectome® should not create an external filtering bleb or requireleaving a permanent hole in the eye. Instead, the Trabectome®electo-surgical handpiece opens access to the eyes natural drainagesystem. This procedure is performed through a small incision similar tothat of cataract surgery and allows the patient to go home on the sameday.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying figures, which are incorporated into and form a part ofthe specification, illustrate several embodiments of the presentinvention and, together with the description, serve to explain theprinciples of the invention. The figures are only for the purpose ofillustrating a preferred embodiment of the invention and are not to beconstrued as limiting the invention.

FIG. 1 shows an angled, side view of one embodiment of the device withan enlarged detailed view of the operative end of the device with thebeveled platform.

FIG. 2 shows an angled, side view of one embodiment of the device withan enlarged detailed view of the operative end of the device with thebeveled platfrom 5. The shaded aspect provided a view of the dimensionsof the beveled platform. The angle of tool shaft 3 attachment and offirst and second blade attachment relative to the beveled platfrom 5 areindicated.

FIG. 3 shows a front face view of one embodiment of the device with anenlarged detailed view of the operative end of the device with thebeveled platfrom 5. Shown are examples of the different angles ofattachment of the handle 1 to the beveled platfrom 5 clockwise 0, 15,and 30 degrees relative to the Z-axis and X-axis. The increased platformthickness is also indicated as the platform extends from the insertiontip 6 towards the back of the platform 7 and from the first side (on theright) to the second side (on the left).

FIG. 4A, B, & C present exemplary embodiments of a dual platform/dualblade ophthalmic knife. FIG. 4A depicts bi-directional configuration 35of two platforms configured at a 180° angle. FIG. 4B depicts a parallelconfiguration of two platforms. FIG. 4C depicts an offset configurationof the first and second platforms.

FIG. 5 presents an exemplary embodiment of quad-blade ophthalmic knifecomprising two platform blades (10 and 11) and two shaft blades (30 and31). In one embodiment, the two upper (shaft) blades positioned abovethe lower (platform) blades, the upper and lower blades being able tomove up and down to cut TM between the upper and lower blades (likescissors on either side of the ramp). In one embodiment, the tipperblades may be moved by triggering a mechanism, such as squeezing thehandle (like MST forceps).

FIG. 6 depicts one embodiment of the ultrasonic ophthalmic knife.

FIG. 7 presents an exemplary embodiment of a pincer ophthalmic knifecomprising a lower platform comprising at least two blades and a hingedupper platform having a complementary surface to the lower platform. Inone embodiment, said first platform is guided into the canal whilst thesecond platform is inside said handle, tool shaft, or barrel. In oneembodiment, said first platform is advanced into TM and subsequentlysaid second platform is then pushed down towards said first platform tocapture TM between said first platform and second platform. In oneembodiment, said platforms further comprise blades or recesses on bothsaid first platforms and said second platform. In one embodiment, saidplatforms have curved surfaces. In one embodiment, said platforms havecomplementary surfaces. In one embodiment, said complementary surfacesarticulate at a surface of articulation. In one embodiment, said surfaceof articulation is the edge of said blades. In one embodiment, saidplatforms marry to each other and amputate the strip of TM in one 8 mmstrip.

FIG. 8 presents an exemplary embodiment of a gripping ophthalmic knifecomprises a shaft connected to one pair of serrated jaws (e.g.,alligator clips).

FIG. 9 presents an exemplary embodiment of a lancet ophthalmic knifecomprising a wire element connected to a shaft.

FIG. 10 presents an exemplary embodiment of an axial opthamic knifecomprising at least two blades connected to a shaft.

FIG. 11 presents an exemplary embodiment of a V-blade ophthalmic knife.

FIG. 12 presents an exemplary embodiment of an ophthalmic knife having aplatform comprising a through-hole.

FIG. 13 presents an exemplary embodiment of an ophthalmic knifecomprises at least one internal lumen.

FIG. 14 presents an exemplary embodiment of an ophthalmic knifecomprising a platform that lacks a ramp (or bevel).

FIG. 15 presents an exemplary embodiment of an ophthalmic knifecomprising a platform attached to two blades, wherein the blades extendfrom the posterior end to the distal anterior blade tip.

LIST OF REFERENCE NUMERALS

-   1 handle-   2 first interface-   3 tool shaft-   4 second interface-   5 platform-   6 insertion tip-   7 second end/back of the beveled platform-   8 first side-   9 second side-   10 first blade-   11 second blade-   12 device-   13 second platform-   14 third blade-   15 fourth blade-   16 barrel of the device-   17 alligator clip-   18 first alligator clip blade-   19 second alligator clip blade-   20 wire element-   21 axial extension-   22 internal lumen/collector channel-   23 through-hole-   24 fiber optic-   25 ultrasonic emitter-   26 grasping feature-   27 sleeve or cap-   28 sleeve or cap actuator switch-   29 curved platform-   30 first upper blade-   31 second upper blade-   32 handle trigger-   33 blade heating element-   34 lancet type/hollow/wire-   35 double sided/bi-directional device-   36 overhang-   37 no beveled platform, angled blades-   38 wedge-   39 slidable punch

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to an ophthalmic knife and methods of itsuse for treatment of various conditions including eye diseases, such asglaucoma, using minimally invasive surgical techniques. An ophthalmicknife can be used for cutting the tissues within the eye, for example, atrabecular meshwork (TM). This invention also relates to surgicalmedicinal intervention. For example, the present invention relates to amicrosurgical device and methods of its use for treatment of variousmedical conditions including but not limited to eye diseases, such asglaucoma, using minimally invasive surgical techniques.

I. Conventional Treatments for Ocular Diseases

A. Glaucoma

Glaucoma is believed to be one of the leading causes of blindnessworldwide [1]. It has been reported that a modifiable disease riskfactor is intraocular pressure (IOP). Conventional treatment hascentered on lowering IOP pharmaceutically with hypotensive medicationsor surgically through the use of lasers or incisional procedures. Themain area of obstruction to aqueous outflow, with subsequentdysregulation of IOP, is thought to be located at the juxtacanaliculartrabecular meshwork (TM) and distal outflow structures [2-4]. Performinga goniotomy or trabeculotomy in adults with glaucoma has not beenassociated with great success in lowering IOP [5, 6]. In contrast, theseprocedures have been reported to be more successful in congenitalglaucoma, where a membrane covering the TM is thought to be a majorfactor in impedance of aqueous outflow [7]. More recently, there havebeen attempts to use novel ab intern trabeculectomy procedures to removeTM in adult patients and results have been mixed [8-10].

One reason for poor long-term outcomes with this approach in adultsmight be related to incomplete removal of TM and membrane formationacross the remaining TM leaflets with subsequent elevation in IOP [11].It is unclear how a more complete removal of TM tissue might compare toprocedures that simply incise TM, such as an MVR blade goniotomy, orprocedures that cauterize TM with tissue removal, such as Trabectome®(Neomedix, Tustin, Calif., USA). The dual-blade device is specificallydesigned to conform to the drainage angle anatomy of the human eye.While not limiting the current invention, the device is meant to performan ab intern trabeculectomy by engaging TM and cutting the target tissuewhile minimizing leaflets left in place and damage to adjacent tissues.The device was designed and manufactured at the University of ColoradoEye Center (U.S. Provisional Patent Application No. 61/637611) [12].Tissue effects from the novel device are compared to those from agoniotomy using a microvitreoretinal (MVR) blade (BD, Franklin Lakes,N.J., USA) and cautery of TM with the Trabectome® device. Human eyeperfusion studies were also completed to assess the IOP-loweringefficacy of each approach.

Recently, there has been a growing trend toward innovations in minimallyinvasive glaucoma surgery (MIGS). The risks and imperfections of guardedfiltration surgery and tube shunt procedures have driven this paradigmshift despite the proven long-term efficacy of these incisionalprocedures. Drawbacks of traditional incisional procedures includeunpredictable IOP-lowering results, prolonged visual recovery, long-termrisk of infection and vision loss, frequency of follow-up visits, andlong-term failure rate [13]. Procedures such as endoscopiccyclophotocoagulation, ab intern trabeculectomy with Trabectome®, andcanaloplasty with the iScience illuminated catheter (iScience, MenloPark, Calif., USA) were all introduced to address limitations offull-thickness surgery, most notably to eliminate the presence of afiltering bleb. However, a major drawback of all of these procedures isthe additional equipment cost required and, in some cases, a steeplearning curve. The added equipment cost in particular presents asignificant hurdle to providers, hospitals, and surgery centers that mayrequire several procedures to recoup the initial investment. Providersand patients may also face opposition from insurance companies regardingcoverage of a novel procedure lacking longterm efficacy data. Therequirement for additional equipment also limits patient access to theseprocedures in underserved areas of the world.

B. Goniotomy

A goniotomy is generally referred to as a surgical procedure primarilyused to treat congenital glaucoma. It can be caused by a developmentalarrest of some of the structures within the anterior (front) segment ofthe eye. These structures include the iris and the ciliary body, whichproduces the aqueous fluid needed to maintain the integrity of the eye.These structures do not develop normally in the eyes of patients withisolated congenital glaucoma. Instead, they overlap and block thetrabecular meshwork, which is the primary drainage system for theaqueous fluid. Because of this blockage, the trabecular meshwork itselfbecomes thicker and the drainage holes within the meshwork are narrowed.These changes lead to an excess of fluid in the eye, which can causepressure that can damage the internal structures of the eye and causeglaucoma.

In general, congenital glaucoma is caused by a decrease in or even acomplete obstruction of the outflow of intraocular fluid. The ocularsyndromes and anomalies that predispose a child to congenital glaucomainclude the following: Reiger's anomaly; Peter's anomaly; Axenfeld'ssyndrome; and Axenfeld-Rieger's syndrome. Systemic disorders that affectthe eyes in ways that may lead to glaucoma include Marfan's syndrome;rubella (German measles); and the phacomatoses, which includeneurofibromatosis and Sturge-Weber syndrome. Since these disordersaffect the entire body as well as the eyes, the child's pediatrician orfamily doctor will help to diagnose and treat these diseases.

One purpose of a goniotomy is to clear the obstruction to aqueousoutflow from the eye, which in turn lowers the intraocular pressure(TOP). Although it is not necessary to understand the mechanism of aninvention, it is believed that lowering the IOP helps to stabilize theenlargement of the cornea and the distension and stretching of the eyethat often occur in congenital glaucoma. The size of the eye, however,may not return to normal. Most importantly, once the aqueous outflowimproves, damage to the optic nerve is halted or reversed. The patient'svisual acuity may improve after surgery.

Before the surgeon begins the procedure, the patient may be givenmiotics, which are drugs that cause the pupil to contract. The partialclosure may improve the surgeon's view of and access to the trabecularmeshwork; it may also protects the lens of the eye from trauma duringsurgery. Other drugs may be administered to lower the intraocularpressure. Goniotomy procedures may be done without use of miotics. Inone embodiment, the current invention may be used in the setting of adilated (non-miotic) pupil, as can devices described as prior art.

Once the necessary drugs have been given and the patient isanesthetized, the surgeon may use forceps or sutures to stabilize theeye in the correct position. The patient's head may be rotated away fromthe surgeon so that the interior structures of the eye are more easilyseen. Next, with either a knife-needle or a goniotomy knife, the surgeonpunctures the cornea while looking at the interior of the eye through amicroscope or a loupe. An assistant may use a syringe to introduce fluidinto the eye's anterior chamber through a viscoelastic tube as thesurgeon performs the goniotomy.

A gonioscopy lens may be then placed on the eye. As the eye is rotatedby an assistant, the surgeon sweeps the knife blade or needle through90-120 degrees of arc in the eye, making incisions in the anteriortrabecular meshwork, avoiding the posterior part of the trabecularmeshwork in order to decrease the risk of damage to the iris and lens.Endoscopic visualization may also be used to guide cutting. In oneembodiment, the device of the current invention may be place at the endof an endoscope, precluding the need for a gonio lens during treatment.Once the knife and tubing are removed, saline solution may be introducedthrough the hole to maintain the integrity of the eye and the hole isclosed with sutures. The surgeon then applies antibiotics andcorticosteroids to the eye to prevent infection and reduce inflammation.The head may be then rotated away from the incision site so that bloodcannot accumulate. The second eye may be operated on at the same time.If the procedure needs to be repeated, another area of the eye may betreated.

Previous devices have been described in Sorensen et al., “Tubular CutterDevice and Methods For Cutting and Removing Strips of Tissue from theBody of a Patient,” U.S. Pat. No.7,959,641 (Issued Jun. 14, 2011; [14])Also see International Publication No. WO 2004/110501 [15] and UnitedStates Publication No. US 2007/0276420 related parts [16]). Thisreference discloses a device for cutting a strip of tissue with a widthof about 50-200 μm from the trabecular meshwork. The device has a firstand second cutting edge formed on the distal end of the cutting tube.The tip can be blunt and in some applications is configured and used tofacilitate the insertion of the device into its intended location i.e.Schlemm's canal. Further, one or more bends or curves may be optionallyformed to facilitate its use. The tip of the device may be advancedthrough the trabecular meshwork and into the Schlemm's canal therebycausing the cutting edges to cut a strip of the trabecular meshwork,thereby creating an opening for drainage of aqueous humor. While thisreference teaches a cutting blade with dual cutting sides and a tip forplacement into Schlemm's canal for removal of trabecular meshwork withoptional bends/curvatures it does not specifically mention use of a 0.3mm blade width.

Another device is described in Huculak, “Small Gauge Mechanical TissueCutter/Aspirator Probe for Glaucoma Surgery,” United States PatentPublication No. US 2009/0287233 [17]. This reference discloses use of asmall gauge mechanical tissue cutter/aspirator probe to removetrabecular meshwork. The probe can be guided into Schlemm's canal andmoved in a forward motion following the curvature of the trabecularmeshwork. The motion causes the trabecular meshwork to be fed into thecutting port of the cutter, thereby cutting and removing the trabecularmeshwork that blocks the outflow of aqueous humor. Due to the size ofSchlemm's canal, it is preferable to have the distal end of the outercannula measure about 0.25 to 0.36 mm diameter. The cannula can betapered so its distal end measures about 0.25 to 0.36 mm (Schlemm'scanal is about 0.3 mm). Further, the leading edge can be curved toenhance its ability to pierce the trabecular meshwork. While thereference teaches use of a small gauge cutter with a diameter of about0.25 to 0.36 mm with a sharp or blunt leading edge for piercing thetrabecular meshwork and entry into Schlemm's canal with a cutting portto cut the trabecular meshwork it does not per se teach a dual sharpedge cutting blade.

Another device is described in Baerveldt et al., “Minimally InvasiveGlaucoma Surgical Instrument and Method,” United States PatentPublication No. US 2011/0077626 [18] (Also see U.S. Pat. No. 7,785,321[19] and 6,979,328 [20]; and United States Patent Publication No. US2006/0106370 [21] and US 2002/0111608 [22] selected parts). Thisreference discloses use of a cutting probe to cut and remove trabecularmeshwork. The probe comprises a tip that is approximately 25 gauge(about 0.5 mm). The tip further comprises a footplate that serves as aguide into Schlemm's canal. The sharpened end of the footplate is usedto pierce the trabecular meshwork. The trabecular meshwork is cut usinga rotatable blade or cut in a guillotine fashion. While the referencediscloses use of a cutting probe with a tip approximately 25 gaugeincluding a footplate for piercing the trabecular meshwork and targetingSchlemm's canal it does not per se mention use of a dual sharp edgecutting blade sized for navigating Schlemm's canal (0.3 mm). Anotherdevice is described in Huculak, “Small Gauge Mechanical TissueCutter/Aspirator Probe for Glaucoma Surgery,” International PublicationNo. WO 2009/140185 [23] (Also see European Patent No. EP 2303203 [24]selected parts). This reference discloses use of a small gaugemechanical tissue cutter/aspirator probe to remove trabecular meshwork.The probe consists of an outer cannula and an inner cannula. The innercannula's distal end is configured to cut tissue when it enters port310. The inner cannula is moved up and down to cut tissue. The outercannula includes a retractable pick that has a sharp end for piercingthe trabecular meshwork. Due to the size of Schlemm's canal, it ispreferable to have the distal end of the outer cannula measure about0.25 to 0.36 mm in diameter. The cannula can be tapered so its distalend measures about 0.25 to 0.36 mm (Schlemm's canal is about 0.3 mm).While the reference discloses use of a probe sized between 0.25 and 0.36mm for piercing the trabecular meshwork and placement into the Schlemm'scanal, it does not mention use of a dual sharp edge cutting blade with acurvature for navigating Schlemm's canal.

Another device is described in Bergheim, O. B. and Gharib, M. “Apparatusand Method for Treating Glaucoma,” WIPO Patent WO/2001/078631Application PCT/US2001/007398, filed Mar. 8, 2001. (Published Oct. 25,2001) [25]. This reference discloses use of a cutting member positionedat the distal end of a tube consisting of a knife, a pointed guidemember, and a sharpened distal end of said tube. The cutting member isconfigured to form an opening in the trabecular meshwork for placementof a seton into Schlemm's canal. The knife includes a microknife sizedwithin the range of 20 to 40 gauge preferably 30 (0.3 mm) gauge. Whilethe reference discloses use of a cutting member sized from 20 to 40gauge for cutting the trabecular meshwork and delivery of a seton toSchlemm's canal it does not mention use of a dual sharp edge cuttingblade with a curvature for navigating Schlemm's canal.

Another device is described in Skjaerpe, Finn, “MicrosurgicalInstrument,” U.S. Pat. No. 4,501,274 [26] (Issued Feb. 26, 1985; alsosee European Patent No. EP 0073803 [27] selected parts). This referencediscloses a microsurgical probe with a cutting member comprised of twoknife blades protruding in different directions from the probe each withat least one sharp cutting edge. The cutting member has a double-cuttingknife, where the two cutting edges are angularly separated such thatthey create a V-fount adapted to the local anatomical features of theeye at the Schlemm's canal and the trabecular meshwork. The probediameter is approximately 0.25 mm and the width of the knives is 0.3 to0.5 mm. The knife blades also include a cutting edge on both sides sothe probe can be pulled in both directions through the Canal of Schlemm.While the reference discloses a dual-knife with at least one sharpcutting edge for cutting the trabecular meshwork and the inner wall ofSchlemm's canal it does not per se mention a curvature for navigatingSchlemm's canal.

Another device is described in Conston et al., “Ophthalmic MicrosurgicalSystem,” United States Patent Publication No. US 2006/0149194 [28] (Alsosee International Publication No. WO 2003/045290 [29], European PatentNo. EP 1455698 [30] and Korean Patent No. KR 1020040058309 [31] selectedparts). This reference discloses a microsurgical system with an outermicrocannula sheath that includes an inner member that is sized to adaptto the Schlemm's canal that is about 50 to 200 microns in diameter. Theinner member is in the range of 50-240 microns in outer diameter inorder to fit within the outer cannula, which is 50-250 microns in innerdiameter. The outer microcannula and inner member each are adaptable tothe curvature of Schlemm's canal and the inner member optionallyincludes a cutting tool at the distal end with a diamond or sapphire tipor blade or similar element. While the reference discloses a micro sizedprobe for cutting trabecular meshwork and targeting Schlemm's canal itdoes not per se mention use of a dual sharp edge cutting blade forpiercing the trabecular meshwork and targeting Schlemm's canal.

Another device is described in Conston et al., “Ophthalmic MicrosurgicalInstruments,” United States Patent Publication No. US 2007/0073275 [32](Also see International Publication No. WO 2004/093761 [33] and EuropeanPatent No. EP 1615604 [34] selected parts). This reference discloses amicrosurgical instrument that can be directly inserted into Schlemm'scanal to allow controlled treatment or removal of adjacent tissues suchas TM. The instruments comprise an outer sheath microcannula and aninner member where the distal end of the instruments can be curved toapproximate the curvature of Schlemm's canal. The instruments include acutting means to excise targeted tissue. The microcannula is sized toaccommodate the Schlemm's canal (approximately 200 microns in diameter)approximately ranging from 100 to 350 microns outer diameter. The distaltip of an inner member can be beveled or sharpened to provide a cuttingaction. While the reference discloses a micro sized probe for cuttingtrabecular meshwork and targeting Schlemm's canal it does not per semention use of a dual sharp edge cutting blade for piercing thetrabecular meshwork and targeting Schlemm's canal.

Another device is described in Huculak, “Pulsed Electric Field Probe forGlaucoma Surgery,” United States Patent Publication No. US 2011/0230877[35]. This reference discloses use of a small gauge pulsed electricfield probe for removal of trabecular meshwork. The distal end of theprobe includes a pick adapted to fit into Schlemm's canal so theelectric pulsed field can be used to dissociate and remove thetrabecular meshwork. The pick has a sharp end so it can pierce thetrabecular meshwork and so the pick can be placed into the Schlemm'scanal. The pick is retractable. The probe has a diameter between 0.25and 0.36 mm. While the reference discloses use of a probe sized between0.25 and 0.36 mm for piercing the trabecular meshwork and placement intothe Schlemm's canal, it does not mention use of a dual sharp edgecutting blade with a curvature for navigating Schlemm's canal.

Another device is described in Pantcheva, M. B. and Kahook, M. Y. (2010)Ab Interno Trabeculectomy, Middle East Afr. J. Ophthalmol. 17(4),287-289 [10]. This reference is a review of the Trabectome® device thatis used in this general field.

Another device known in the art that has been used for ab interntrabeculectomy is known as the “gonioscraper,” as described by Jacobiand associates [36]. This device consisted of a handle and curette tipand was used to remove TM by scraping the curette within the Schlemm'scanal. The curette tip is in line with the handle and does not conformto the geometry of the drainage angle and adjacent structures. Afterpromising preclinical experiments, a nonrandomized clinical trial of 25eyes was completed [37]. Preoperative IOP was 34.7±7.1 mm Hg on 2.2+0.56medications and mean follow-up time was 32 months. Based on the successcriteria of postoperative IOP of 19 mm Hg or less with 1pressure-reducing agent, 15 eyes (60%) were successful. Nonetheless,complications developed in some patients including localized Descemetmembrane detachments and/or anterior chamber bleeding. Histologicanalysis of banked human eyes treated with the curettage showedsuccessful removal of TM tissue, but with damage to the septa andendothelium of the external and posterior wall of the Schlemm's canal[36]. In the data presented herein, similar damage to adjacent sclerawas also observed when using the MVR blade, but was notably absent withuse of one embodiment of a dual-blade device as contemplated by thepresent invention.

There have been reports of both success and failure with the Trabectome®device over the past few years [8-11, 38]. In a recent retrospectivestudy of Trabectome® versus ab externo trabeculectomy, Jea andassociates found poor success rates in eyes treated with Trabectome® at2 years [8]. Of the 115 eyes treated with Trabectome®, only 22.4%achieved success with failure defined as IOP >21 mm Hg or <20% reductionin TOP. It is conceivable that, after initial opening of the canal withTM removal, the residual leaflets occlude the Schlemm's canal and/or themore distal collector channels, leading to failure of the intervention.This mechanism of failure after Trabectome® treatment would be overcomeby the dual-blade device, as a more complete removal of TM tissue isproduced without residual leaflets.

A modified dual blade device geometry was designed to minimize anyimpact to adjacent tissues such as Descemet membrane by leveragingspecific angles between the handle and the distal blade as well as useof specific angles between the cutting blade and the adjacent cuttingtip. Kahook M., WO 2013/163034 [39] (herein incorporated by reference).Several practical advantages of a dual blade device for use in ab interntrabeculectomy were reported. First, a dual blade device may be reusableand can be added to a standard cataract surgical tray. Second, the lackof moving parts or the need for coupled irrigation or a separate powersource allows for inexpensive manufacturing and rapid acquisition ofsurgical expertise. This would permit easy, economical access to a newtechnique, especially in underserved locations around the world. Forcomparison, a conventional Trabectome® device requires a substantialinitial investment for the irrigation/aspiration unit and generator inaddition to the cost of one-time-use items such as the hand piece andtubing. The simple design and material requirements of dual-blade deviceembodiments would be more economical. Finally, in contrast to othertechniques for TM removal, embodiments of dual-blade device designsconform to the Schlemm's canal anatomy, minimizes damage to adjacenttissues, and provides excellent control over excised tissue. Inconclusion, the conventional dual-blade device may perform ab internotrabeculectomy with or without concomitant cataract extraction.

II. Ophthalmic Knives

The following detailed description, and the drawings to which it refers,are provided for the purpose of describing and illustrating certainpreferred embodiments or examples of the invention only, and no attempthas been made to exhaustively describe all possible embodiments orexamples of the invention. Thus, the following detailed description andthe accompanying drawings shall not be construed to limit, in any way,the scope of the claims recited in this patent application and anypatent(s) issuing there from.

In one embodiment, the present invention contemplates an ophthalmicknife for cutting ocular tissue (e.g., for example, trabecular meshwork(TM)). In particular, the knife may have a device tip providing entryinto the Schlemm's canal via its size (i.e., for example, betweenapproximately 0.3-0.2 mm width) and a configuration where the entryblade tip curves up providing a ramp-like action for cutting tissue(e.g., for example, trabecular meshwork tissue).

Specific advantages of some embodiments described herein as compared toother conventional devices include but are not limited to:

-   -   1. No mechanically moving parts    -   2. No cautery or burning of tissue    -   3. A multi-blade configuration can be in place on the sides of        the device that cut the TM in a precise fashion leaving little        TM behind (current devices leave considerable residual TM        leaflets behind that then scars over)    -   4. The entry into Schlemm's canal is done with use of the blade        tip. Other similar devices use a non-blade footplate to enter        Schlemm's canal.    -   5. The dimensions of these devices allow for a complete cutting        and fit in Schlemm's canal with precision.    -   6. A tip of the blade may ramp up to the multiple side blades        forming a surface that presents the TM to the blades, which then        allows for more precise cutting.    -   7. A device distal end is a right triangle that follows the        a²+b²=c².    -   8. The distal end ramps up from the piercing blade towards to        parallel blades that are positioned above the level of the TM.    -   9. The ramp causes the TM to elevate away from canal of schlemm        as the device is advanced thus lifting the TM above the usual        position of the inner wall of the canal of Schlemm.    -   10. Once the TM is elevated and the device is advanced, the TM        presents to the parallel blades resulting in a clean cut of the        tissue.    -   11. The stretch of the tissue away from the natural position of        the inner wall of the canal of schlemm is a key step for        success.    -   12. The piercing tip blade is not continuous with the blades on        the top of the ramp (i.e., there is no sharp part that is        continuous from the tip all the way to the blades that cut the        TM). The area of the ramp is generally devoid of a cutting edge.    -   13. In one embodiment, the device has a flat bottom which        results in the bulk of the bottom of the device not touching the        outer wall of Schlemm's canal once the device is placed flush        with heel down (the curve of canal of Schlemm results in this        (so the bottom of the footplate is cupped by canal of schlemm).        This means less contact and friction with the footplate of the        current invention as it is advanced.    -   14. All cutting of tissue (except for the initial piercing with        the blade tip) is done away from (elevated towards the anterior        chamber) canal of Schlemm.

A. An Ophthalmic Knife Platform

In some embodiments, the present invention contemplates an ophthalmicknife comprising a platform. In some embodiments, the platform comprisesa ramp, thereby forming a beveled, or wedge shape 38. In someembodiments, the platform is attached to lateral blades, preferably onthe lateral sides of the platform, see FIG. 1.

In one embodiment, a first lateral blade 10 and a second lateral blade11 are in a perpendicular alignment to the bottom of the beveledplatfrom 5. In one embodiment, the invention relates to a device 12comprising a handle 1 and a beveled platform 5, wherein said platfrom 5is set at a specific angle and orientation relative to said handle 1. Inone embodiment, the invention relates to a device 12 comprising a handle1 and a beveled platform 5, wherein said platfrom 5 freely rotates in atleast two dimensions. In one embodiment, said handle 1 and beveledplatfrom 5 are operably attached at an angle ranging between 90 and 120degrees in the Y-Z axis. In one embodiment, said handle 1 and beveledplatfrom 5 are operably attached at an angle ranging between 90 and 180degrees in the X-Z axis. In one embodiment, said platfrom 5 freelyrotates in an X-Y dimension relative to said handle 1. In oneembodiment, said platfrom 5 remains at a fixed angle in the X-Y, X-Z,and Y-Z dimensions relative to said handle 1. In one embodiment, saidplatfrom 5 freely rotates in a positive Z dimension relative to saidhandle 1. In one embodiment, said beveled platfrom 5 comprises a firstend/beveled platform tip/insertion blade tip 6 and a second end/back ofthe beveled platform 7, wherein said second end/back of the beveledplatform 7 is between two and thirty times greater in thickness relativeto said first end/beveled platform tip/insertion blade tip 6. In oneembodiment, the dimensions of the beveled platforms 5 are dictated bythe formula A²+B²=C², wherein A is the length of said beveled platfrom 5from said insertion blade tip 6 to the back of the beveled platform 7, Bis the height of the beveled platfrom 5 and C is the length of the ramp.In one embodiment, the height of said beveled platfrom 5 is not toexceed 0.5 millimeters. In one embodiment, the length of said beveledplatfrom 5 from said insertion blade tip 6 to the back of the beveledplatform 7, is not to exceed 1.0 millimeters. In one embodiment, saidfirst end/beveled platform tip/insertion blade tip 6 comprises a finesurgical lancet. In one embodiment, said first end/beveled platformtip/insertion blade tip 6 comprises an angle of between 20 and 90degrees. In one embodiment, said beveled platfrom 5 increases inthickness from a fine blade tip towards the second end/back of thebeveled platforms 7 in the direction of the Y-axis. In one embodiment,said first end/beveled platform tip/insertion blade tip 6 comprises apointed tip with fine edges of surgical sharpness. In one embodiment,said first end/beveled platform tip/insertion blade tip 6 comprises alancet. In one embodiment, said beveled platfrom 5 further comprises afirst blade 10 and a second blade 11. In one embodiment, said firstblade 10 is attached to a first side 8 of said second end/back of thebeveled platform 7. In one embodiment, said first blade 10 and beveledplatfrom 5 are operably attached at an angle ranging between 90 and 180degrees in the Y-Z axis. In one embodiment, said angle is preferablybetween 90 and 120 degrees in the Y-Z axis. In one embodiment, saidsecond blade 11 and beveled platfrom 5 are operably attached at an angleranging between 90 and 120 degrees in the Y-Z axis. In one embodiment,said first blade 10 and handle 1 are operably positioned at an angleranging between 90 and 120 degrees in the Y-Z axis. In one embodiment,said second blade 11 and handle 1 are operably positioned at an angleranging between 90 and 120 degrees in the Y-Z axis. In one embodiment,said second blade 11 is attached to a second side 9 of said secondend/back of the beveled platform 7. FIG. 2. In one embodiment, whereinsaid anterior blade tip is a retractable blade tip.

In one embodiment, said beveled platfrom 5 increases in thickness fromsaid second side 9 towards the first side 8 in the direction of theX-axis. FIG. 3. In one embodiment, said beveled platfrom 5 increases inthickness from said second side 9 towards the first side 8 in thedirection of the X-axis and said beveled platfrom 5 increases inthickness from a fine blade tip of the first end 6 towards the secondend/back of the beveled platform 7 in the direction of the Y-axis.

In one embodiment, said beveled platfrom 5 increases in thickness fromsaid first side 8 towards the second side 9 in the direction of theX-axis. In one embodiment, said beveled platfrom 5 increases inthickness from said first side 8 towards the second side 9 in thedirection of the X-axis and said beveled platfrom 5 increases inthickness from a fine blade tip of the first end 6 towards the secondend/back of the beveled platform 7 in the direction of the Y-axis. Inone embodiment, said first blade 10 and said second blade 11 extendabove the top surface of said second end/back of the beveled platform 7.In one embodiment, said first blade 10 and said second blade 11 arepositioned at an angle between approximately 100 to 140 degrees relativeto the top surface of said second end/back of the beveled platform 7. Inone embodiment, said beveled platfrom 5 is approximately 0.3 millimeterswide. In one embodiment, said beveled platfrom 5 is approximately 0.2millimeters wide. In a preferred embodiment, said beveled platfrom 5 isapproximately 0.25 millimeters wide. In one embodiment, said beveledplatform 5 is approximately 1.0 millimeters long. In one embodiment,said beveled platfrom 5 is approximately 0.4 millimeters high. In oneembodiment, said highest point on the beveled platfrom 5 is the firstand second blades. The device 12, may be provided as a pre-sterilized,single-use disposable probe or tip that is attachable to a standardsurgical handpiece. In one embodiment, the device further comprises afiber optic visualization system 24. In one embodiment, said shaft 3further comprises a grasping feature 26. In one embodiment, saidgrasping feature 26 is selected from the group consisting of a tweezerelement and a forcep element. In one embodiment, said grasping feature26 comprises a sleeve 27 extending over said shaft, wherein said handlecomprises a sleeve actuator switch.

B. A Dual Platform/Dual-Blade Ophthalmic Knife

In one embodiment, the present invention contemplates a dualplatform/dual-blade ophthalmic knife comprising a handle 1 connected toa shaft 3, said shaft connected to a first platform and a secondplatform, said first platform comprising a first and second blade and afirst anterior blade and said second platform comprising a third 14 andfourth 15 blade and a second anterior blade tip. In one embodiment,depicted in FIG. 4A, said device comprises two oppositely facedplatforms with each platform each having at least two lateral blades andeach having a blade tip. In another embodiment, depicted in FIG. 4B, thedevice comprises two roughly parallel platforms with each platform eachhaving at least two lateral blades and each having a blade tip. In oneembodiment, said first and second anterior blade tips are retractableblade tips. In another embodiment, the device comprises at least twooffset platforms. In another embodiment, the device comprises at leasttwo offset platforms each having at least two lateral blades and eachhaving a blade tip

C. A Quad-Blade Ophthalmic Knife

In one embodiment, the present invention contemplates a quad-bladeophthalmic knife comprising a handle 1 connected to a shaft 3, saidshaft connected to a platform comprising four cutting blades and ananterior blade tip, see FIG. 5. In one embodiment, the two upper (shaft)blades (30 and 31) positioned above the lower (platform) blades (10 and11), the upper and lower blades being able to move up and down to cut TMbetween the upper and lower blades (like scissors on either side of theramp). In one embodiment, the upper blades may be moved by triggering amechanism 32, such as squeezing the handle 1 (like MST forceps).

D. An Ultrasonic Ophthalmic Knife

In one embodiment, the present invention contemplates an ultrasonicophthalmic knife comprises a handle 1, shaft 3, an anterior blade tip,and platform wherein the platform comprises an ultrasonic emitter 25. Inone embodiment, said ultrasonic ophthalmic knife is shown in FIG. 6.

E. A Pincer Ophthalmic Knife

In one embodiment, the present invention contemplates a pincerophthalmic knife comprising a handle 1 connected to a shaft 3, saidshaft connected to a lower platform and an upper platform. In oneembodiment, said platforms are curved. In one embodiment, said firstplatform is guided into the canal whilst the second platform is insidesaid handle 1, tool shaft 3, or barrel 16. In one embodiment, said firstplatform is advanced into TM and subsequently said second platform isthen pushed down towards said first platform to capture TM between saidfirst platform and second platform. In one embodiment, said platformsfurther comprise blades or recesses on both said first platforms andsaid second platform. In one embodiment, said platforms havecomplementary surfaces. In one embodiment, said complementary surfacesarticulate at a surface of articulation. In one embodiment, said surfaceof articulation is the edge of said blades. In one embodiment, saidplatforms marry to each other and amputate the strip of TM in one 8 mmstrip. In one embodiment, said device is depicted in FIG. 7.

F. A Gripping Ophthalmic Knife

In one embodiment, the present invention contemplates a grippingophthalmic knife comprising a handle 1 connected to a shaft 3, saidshaft comprises a lateral alligator clip 17, a platform connected to theshaft 3, said platfrom 5 comprising a first lateral blade 10 a, and ananterior blade tip 6. In one embodiment, said alligator clip 17comprises a first 18 and second 19 alligator clip blades. In oneembodiment, said alligator clip 17 comprises a clip with a spring thatcloses the articulating jaws. In one embodiment, said alligator clipcomprises a clip with a spring that closes the serrated jaws. An exampleof an alligator clip (17) is shown in FIG. 8. In one embodiment, onlythe top jaw of said alligator clip moves up and down. In one embodiment,the bottom jaw of said alligator clip stays in the Schlemm's canal. Inone embodiment, the elliptical motion of the top jaw of said alligatorclip draws in the TM, cuts it, and then pushes it out from the backside.

G. A Lancet Ophthalmic Knife

In one embodiment, the present embodiment contemplates a lancetophthalmic knife comprising a handle 1 connected to a shaft 3, saidshaft connected to a wire element 20. In one embodiment, the shape ofsaid wire element may retract into said shaft 3. In one embodiment, saidwire element is rigid. In one embodiment, the shape of said wire elementmay be various, from having a tip to as simple as a square wire. In oneembodiment, said wire element 20 has at least one sharp edge. In oneembodiment, said wire element 20 has at least one dull edge. In oneembodiment, said wire element 20 has a square shape, as depicted in FIG.9. In one embodiment, said wire element 20 can be a triangle, square,rectangle, or an ellipse. In one embodiment, said wire element 20 ispushed into the TM. In doing so said wire element 20 stretches open theSchlemm's canal a bit. The wire element 20 is then advanced through thecanal so that the sharp wire cuts the TM leaving a long trailing stripof TM.

H. An Axial Blade Ophthalmic Knife

In one embodiment, the present invention contemplates an axial bladeophthalmic knife comprising a handle 1 connected to a shaft 3, saidshaft connected to a first and second blade. In one embodiment, saidaxial blade comprises an axial extension 21 comprising at least onedistal blade. In one embodiment, said distal blade is affixed to saidaxial extension wherein the distance between said blade and the edge ofsaid axial extension distal tip comprises an overhang 36. In oneembodiment, said overhang 36 limits the depth of the cut. In oneembodiment, depicted in FIG. 10, said device comprises two parallelblades (10 and 11) attached to said axial extension 21, wherein thespace between the blades and the edge of said axial extension 21comprises an overhang 36.

I. A V-Blade Ophthalmic Knife

In one embodiment, the present invention contemplates a V-bladeophthalmic knife comprising a handle I connected to a shaft 3 comprisinga first blade, said shaft connected to a platform, wherein the firstblade overhangs said platform such that the first blade and saidplatform are connected at an angle. In one embodiment, the angle ofattachment and overhand of said shaft 3 to said platform provides asurface for shearing tissue. In one embodiment, said knife furthercomprises a pass through window for cut tissue. FIG. 11 provides a sideview of one embodiment of this device, wherein the dashed linesindicates one embodiment of the internal through-hole 23.

III. Construction Materials

It is not intended that embodiments of the invention be limited to anyparticular construction material; however, it is believed that preferredmaterials include titanium, stainless steel, polyether ether ketone(PEEK), ceramics, rigid plastics, shape memory alloy such as nitinol,and shape memory polymers. In some embodiments, the platform is made ofsilicon or another polymer or a hydrogel.

In some embodiments, the knives as contemplated herein may be made of amaterial that is transparent to optical coherence tomography (OCT)wavelengths (e,g,m typically 800-1600 nm). In one embodiment, an OCTtransparent material includes, but is not limited to glycol modifiedpoly(ethylene terephthalate), polyvinyl chloride, poly(methylmethacrylate), or polyphenylsulfone. Although it is not necessary tounderstand the mechanism of an invention, it is believed that thesematerials allow the performance of intraoperative OCT during intraocularsurgery without any visual interference by the ophthalmic knife.

In one embodiment, the present device is made from metal alloy materialsdescribed by Furst, J. G. et al. “Metal Alloys for Medical Devices,”U.S. Pat. No. 7,648,591 [40], Richter, K. “Amorphous Metal Alloy MedicalDevices,” U.S. Pat. No. 7,955,387 [41], all herein incorporated byreference. In one embodiment, the present device is made from a shapememory polymer materials described by Reimink, M. S. and Ogle, M. F.“Medical Devices with Polymer/Inorganic Substrate Composites,” U.S. Pat.No. 7,604,663 [42], Langer, R. S. and Lendlein, A. “Shape MemoryPolymers,” U.S. Pat. No. 6,388,043 [43], Langer, R. S. and Lendlein, A.“Shape Memory Polymers,” U.S. Pat. No. 6,720,402 [44], Tong, T. H.“Shape Memory Styrene Copolymer,” U.S. Pat. No. 6,759,481 [45], Stalker,K. C. B. et al. “Variable Stiffness Medical Devices,” U.S. Pat. No.7,632,303 [46], Anthamatten, M. L. and Li, J. “Shape Memory Polymers,”U.S. Pat. No. 7,935,131 [47], and Berger, E. J. et al. “Methods ofForming a Part Using Shape Memory Polymers,” U.S. Pat. No. 8,038,923[48], all herein incorporated by reference. In some embodiments, thedevice of the current invention is rigid at room temperature, but ismore flexible at body temperature. In some embodiments, the portions ofthe device of the current invention are rigid at room temperature, butare more flexible at body temperature. In some embodiments, portions ofthe device are made from different materials. In some embodiments,portions of the device are made from materials of various rigidity. Inone embodiment, said shaft is flexible. In some embodiments, said shaftis made from a lower density material.

It is not intended that embodiments of the invention be limited to anyparticular construction material; however, it is believed that preferredmaterials include titanium, stainless steel, polyether ether ketone(PEEK), shape memory alloy, and shape memory polymers. In someembodiments, the device of the current invention is rigid at roomtemperature, but is more flexible at body temperature. In someembodiments, the portions of the device of the current invention arerigid at room temperature, but are more flexible at body temperature. Insome embodiments, portions of the device are made from differentmaterials. In some embodiments, portions of the device are made frommaterials of various rigidity. In one embodiment, said tool shaft 3 isflexible. In some embodiments, said shaft is made from a lower densitymaterial.

C. Methods Of Using The Multi-Blade Ophthalmic Knifes

In one embodiment, the present invention contemplates, a method forusing an ophthalmic knife, comprising: a) providing an ophthalmic knifeselected from the group consisting of a dual platform/dual bladeophthalmic knife, a quad-blade ophthalmic knife, an ultrasonicophthalmic knife, a pincer ophthalmic knife, a gripping ophthalmicknife, a lancet ophthalmic knife, an axial blade ophthalmic knife and aV-blade ophthalmic knife; b) advancing said ophthalmic knife through anincision to a tissue target site; and c) cutting a strip of tissue fromsaid target site.

Detailed Differences Between the Devices

It is not intended that embodiments of the invention be limited to anyparticular method, medical target, or device confirmation; however, itis believed that the device may be optimally designed to removetrabecular meshwork of the eye, unroofing small vessels (such as veins,arteries, lymphatic vessels, or other vessel with a lumen), and forcreating a hole or opening in the tympanic membrane of the ear. It isnot intended that embodiments of the invention be limited to anyparticular mechanism; however, it is believed that creating an openingin the tympanic membrane of the ear may help aid in treating eardisease.

It is not intended that embodiments of the invention be limited to anyparticular endoscope, it is believed that the device may be optimallydesigned for an ophthalmic endoscopy system endoscope. One such systemis commercially called “Endo Optiks.”

Thus, specific compositions and configurations of multiple blade cuttingsystems have been disclosed. It should be apparent, however, to thoseskilled in the art that many more modifications besides those alreadydescribed are possible without departing from the inventive conceptsherein.

All publications mentioned herein are incorporated herein by referenceto disclose and describe the methods and/or materials in connection withwhich the publications are cited. The publications discussed herein areprovided solely for their disclosure prior to the filing date of thepresent application. Nothing herein is to be construed as an admissionthat the present invention is not entitled to antedate such publicationby virtue of prior invention. Further, the dates of publication providedmay be different from the actual publication dates, which may need to beindependently confirmed.

Experimental

Approval for a preclinical study [49] was obtained from the ColoradoMultiple Institutional Review Board for the use of human material priorto initiation of the study and the tenets of the Declaration of Helsinkiwere followed. Informed consent was obtained from donors or relativesfor use in research by the eye bank from which human globes wereobtained.

EXAMPLE I Histological Analysis

Six (6) corneal rim specimens were obtained from the Rocky MountainLions Eye Bank (Aurora, Colo., USA) and the San Diego Eye Bank (SanDiego, Cali., USA). Tissue samples were removed from the storage mediumand mounted on a platform with the TM side facing up and secured inplace using tissue pins. A total of 2 samples were used for each of the3 treatment methods studied. An MVR blade was used to incise the centralTM under microscopic visualization along the length of 2 corneal rims.For the Trabectome® device, the foot plate of the device tip wasinserted into the Schlemm's canal under microscopic visualization. Oncein place, the foot pedal was used to apply continuous ablation whileadvancing the tip slowly across the extent of the TM sample. A standardpower setting of 0.8 W was used during treatment. A dual-blade devicewas used to incise the TM of 2 samples. The blade tip was used to inciseTM in a manner similar to that used for goniotomy and the blade was thenadvanced in a clockwise fashion along the extent of the TM. At thedistal end, the blade tip was tilted upwards to incise a complete ribbonof TM and the process was repeated in a counterclockwise fashion toincise the remaining TM tissue.

All tissue samples were then immediately preserved in 4%paraformaldehyde/phosphate-buffered saline overnight at 4 ° C. and thenradially cut into quadrants. Rim sections were processed for histologyand embedded into paraffin so that the cut edge of the tissue was facingthe front of the block. Tissue sections (6 mm thick) were cut andstained with Mayer's hematoxylin-eosin Y (Richard-Allan Scientific,Kalamazoo, Mich., USA). Bright-field imaging was performed using a NikonEclipse 80i microscope (Nikon, Melville, N.Y., USA) equipped with aNikon D5-Fil color camera and a Nikon CFI 103/Plan Fluor objective lens.

EXAMPLE II Human Eye Perfusion

A total of 12 human globes from pseudophakic donors with no history ofglaucoma were obtained from various eye banks around the country forperfusion studies on each device. The perfusion system used a standardprogrammable syringe pump (Pump 11 Plus; Harvard Apparatus, Holliston,Massachusetts, USA). Pressure was monitored via an in-line real-timepressure transducer (Research Grade Pressure Transducer; HarvardApparatus) connected to a single-channel chart recorder (PharmaciaREC-481; Pharmacia/Pfizer New York, N.Y., USA). Polyethylene tubing witha 1.14 mm inner diameter (PE-160; Warner Instruments, Hamden, Conn.,USA) was used for all connections.

In each case, the human globe was first prepared by injecting Dulbecco'smodified Eagle medium (DMEM; Invitrogen/Life Technologies, Carlsbad,Calif., USA) through the optic nerve with a 26-gauge needle until theglobe had returned to a spherical shape. The perfusion line (terminatingin another 26-gauge needle) was inserted diagonally through the anteriorchamber of the eye, passing through the cornea and pupil and ending withthe tip beneath the iris. The globe was surrounded by damp gauze and theperfusion pump (filled with DMEM) was set to an initial inflow rate of 7mL/min IOP was allowed to increase until it reached 30 mm Hg. Theinfusion rate was then reduced to 2-5 mL/min to maintain a steady-stateIOP for at least 60 minutes prior to TM incision. A preoperative IOP wasmeasured immediately prior to incision in each case. A 1.7 mm stainlesssteel keratome blade (BD) was used create a tri-beveled clear cornealincision near the limbus, and the anterior chamber was filled withenough viscoelastic (HealonGV; Abbott Medical Optics, Abbott Park, Ill.,USA) to maintain the anterior chamber and provide adequate visualizationduring the procedure in each case. Each technique was performed undergonioscopic view using a standard direct gonioscope with microscopeassistance. The surgical procedure used for each device is describedabove. In each case, approximately 100-180 degrees of TM was treated.For each device, treatment was started 180 degrees away from the cornealwound and extended along the angle in a clockwise direction. The devicewas then extended in a counterclockwise direction from the same startingpoint. Every effort was made to treat the maximum amount of degreespossible with each device.

In the case of a conventional modified dual-blade device and aTrabectome®, the instrument was rotated 180 degrees after the initialpass to direct the device tip in the direction of treatment. IOP wasallowed to reach a steady state before measuring the postprocedure IOP.Each of the 3 studied surgical techniques was performed on a total of 4eyes.

Two corneal rim sections were analyzed for each device. Six-micron-thickhistologic sections were taken from various clock hours treated witheach device and stained with Mayer's hematoxylin-eosin Y (Richard-AllanScientific). Findings were consistent across all sections from eachdevice tested. Cuts with the MVR blade exhibited complete incisionthrough the entire thickness of TM tissue. However, there was minimalremoval of TM with large leaflets of tissue remaining over the Schlemm'scanal. The incision extended deeply through the Schlemm's canal withobvious injury to the adjacent deep sclera in the majority of sections(FIG. 1). The Trabectome® also achieved an opening through the entiretyof TM tissue into the Schlemm's canal. Although the device also removeda large portion of the central TM, significant leaflets of residualtissue still remained. The residual TM demonstrated extensive charringfrom thermal injury. Tissue debris was also noted to be occluding distalcollector channels (FIG. 2). Tissue incised with the dual-blade devicedemonstrated a more complete removal of TM without collateral damage(FIG. 3).

Data from human eye perfusion studies are included in Table 1. Theextent of TM treatment varied between devices and between eyes from 100to 180 degrees. All 3 treatment modalities achieved a significantreduction in measured IOP 30 minutes after treatment. Treatment with thedual-blade device and Trabectome® resulted in a mean TOP reduction of40% each, whereas the MVR blade achieved a 31% reduction. Although thepercentage of TOP decrease was greater for Trabectome® and thedual-blade device, there was no statistically significant difference inthe TOP lowering between devices (dualblade/MVR P =.13;dual-blade/Trabectome® P =.96; Trabectome®/MVR P =.12). There was nocorrelation between the number of degrees of TM treated and thepercentage TOP change for any device (r2 =0.077-0.271).

TABLE 1 Human Eye Perfusion Studies After Treatment of TrabecularMeshwork by Various Conventional Devices Degree of PreprocedurePostprocedure Absolute Percent Eye Angle Treated IOP IOP IOP Change IOPChange P Value Modified 1 140 17 10 −7 −41 Dual-blade 2 180 19 11 −8 −42device 3 130 15  9 −6 −40 4 180 22 14 −8 −36 Mean 157.5 ± 26.3 18.3 ±3.0 11.0 ± 2.2 −7.3 −40 0.00063 MVR blade 1 180 20 14 −6 −30 2 180 20 15−5 −25 3 150 18 12 −6 −33 4 170 16 10 −6 −38 Mean 170.0 ± 14.1 18.5 ±1.9 12.8 ± 2.2 −5.8 −31 0.00018 Trabectome ® 1 120 18 12 −6 −33 2 130 2112 −9 −43 3 100 17 11 −6 −35 4 120 19 10 −9 −47 Mean 117.5 ± 12.6 18.8 ±1.7 11.3 ± 1.0 −7.5 −40 0.00324 IOP = intraocular pressure; MVR =microvitreoretinal.

In the study, the initial preclinical evaluation of an embodiment of thepresent invention, a dual-blade device for the treatment of glaucoma, ispresented [49]. Histologic analysis of human cadaver eye tissue treatedwith the dual-blade device achieved more complete removal of TM tissuewhile avoiding any discernible damage to surrounding tissue. Treatmentwith other methods of TM removal such as MVR blade goniotomy and abintern trabeculectomy with the Trabectome® device failed to attainequivalent histologic results to the novel dual-blade device. Whilehistology data were obtained from ex vivo-treated corneal rims, similarfindings were noted when treatment was performed using the ab internapproach on perfused eyes. The near-absence of TM leaflets with thedual-blade device may be beneficial in reducing the chances of futurephysical obstruction, and the lack of tissue damage may also reduce theinflammatory response or subsequent fibrosis at the surgical site.

In addition to potentially favorable histologic outcomes, the dual-bladedevice resulted in significant TOP lowering in a human eye perfusionmodel. Although all 3 devices yielded similar immediate reduction in TOPafter use in a perfusion model, it is unclear how a more completeremoval of TM tissue and decreased collateral damage with the dual-bladedevice of the present invention will translate into long term surgicaloutcomes when used to treat glaucoma. No correlation was found betweendegrees of TM treated and TOP reduction. It is plausible that TOPreduction may depend more on the number of downstream collector channelsexposed rather than the absolute amount of TM removal alone.

In an effort to provide a low-cost MIGS device that can be widely usedby ophthalmic surgeons, one embodiment of the present inventioncontemplates a novel medical-grade stainless steel dual-blade devicethat can successfully remove TM with no discernible collateral damagewas designed. In one embodiment, the device comprises a unique dual-edgeblade design using precise geometries to allow for more complete removalof TM tissue (FIG. 4A&B). Although it is not necessary to understand themechanism of an invention, it is believed that the procedure isperformed from an ab intern approach and is viscoelastic to maintain theanterior chamber. For example, the size and tip of the blade can allowfor a smooth entry into the Schlemm's canal, similar to techniques usedfor traditional goniotomy procedures. Once in place, the tip is advancedthrough the Schlemm's canal and the TM is elevated along a designed rampthat guides tissue toward a set of blades positioned specifically toincise and remove TM. In contrast to the Trabectome® footplate, which isjuxtaposed between the outer wall of the Schlemm's canal and the innerwall of the Schlemm's canal to provide protection during cautery, thedual-blade device transects TM and elevates TM off of the outer wall ofthe Schlemm's canal. Although it is not necessary to understand themechanism of an invention, it is believed that by elevating the TM alongthe ramp of the device as it moves forward leads to maximal tissueremoval when incised by the superiorly placed and strategically angleddual blades. It is further believed that the angle between the distalcutting edge and the handle is engineered to allow maximal angletreatment through 1 incision while avoiding trauma to the cornea aboveor the scleral spur below. The excised TM may then be removed from theeye with forceps or aspirated during the irrigation/aspiration phase ifcombined with cataract extraction. In addition, the device of thepresent invention can easily pass through clear corneal incisions assmall as 1.2 mm, thus obviating the need for additional incisions whencoupled with phacoemulsification.

EXAMPLE III Traditional Incisional Goniotomy

This procedure begins with an incision in trabecular meshwork extendinginto sclera with large segments of trabecular meshwork. For thisprocedure (considered the gold standard surgery for “cutting” throughthe trabecular meshwork and traditionally called “goniotomy”) an MVRblade was used to incise the trabecular meshwork to create an openinginto Schlemm's canal. A histological sample was provided from aprocedure in which an incision exists through Trabecular meshwork andextends into sclera. There were large leaflets of trabecular meshworkremaining on either side of the incision. These leaflets scar down andclose the opening that was created into Schlemm's canal. This preludesany long-term benefit in intraocular pressure lowering which is the goalof the surgery.

EXAMPLE IV Trabectome® Procedures

For this procedure (designed to replace goniotomy and to improve uponthat procedure by removing sections of trabecular meshwork), aTrabectome® device was used to engage the trabecular meshwork andcautery was applied to the trabecular meshwork. The circle shows an areawhere a small segment of trabecular meshwork was removed; however, thereare large leaflets of trabecular meshwork remaining and charred tissueon either side of the treatment area. Post Trabectome® treatment showedtrabecular meshwork remnants and charring of tissue. Tissue debris isoccluding a collector channel this device “burns” tissue and the burningof tissue creates inflammation that leads to more scar formation thatleads to failure of the surgically induced opening into Schlemm's canal.In addition, due to cautery, many bubbles are formed during theprocedure that makes visualization difficult during the actualprocedure. These issues do not occur with the current invention device,which is a major advantage.

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1. An ophthalmic knife, comprising: a shaft having a posterior end; aplatform connected to the shaft on a side thereof opposite the posteriorend, the platform comprising: a top surface; and a bottom surface,opposite the top surface, wherein a thickness of the platform betweenthe top surface and the bottom surface increases from a first thicknessat an insertion tip of the platform to a second thickness at the shaft;and a channel that extends from the top surface through the posteriorend.
 2. The ophthalmic knife of claim 1, wherein the posterior end isopposite a tip of the platform.
 3. The ophthalmic knife of claim 1,further comprising first and second platform blades that are separatedby a gap and extend from the top surface to the shaft.
 4. The ophthalmicknife of claim 3, wherein the first and second platform blades areconfigured to shear tissue and the hole is configured to receive thetissue.
 5. The ophthalmic knife of claim 3, wherein each of the firstand second platform blades is formed by an overhang opposite the topsurface of the platform.
 6. The ophthalmic knife of claim 3, whereineach of the first and second platform blades form an acute angle withrespect to the top surface of the platform.
 7. An ophthalmic knife,comprising: a shaft; a platform connected to the shaft, the platformcomprising: a top surface; and a bottom surface; first and secondplatform blades that are separated by a gap and extend from the topsurface to the shaft; and a lumen extending through the shaft andterminating at an exit port extending through the bottom surface of theplatform.
 8. The ophthalmic knife of claim 7, further comprising ahandle, wherein the lumen extends longitudinally within the handle, theshaft, and the platform.
 9. The ophthalmic knife of claim 7, wherein theexit port is on the top surface of the platform.
 10. The ophthalmicknife of claim 7, wherein the exit port is opposite the first and secondplatform blades.
 11. The ophthalmic knife of claim 7, wherein the exitport is on the bottom surface of the platform.
 12. The ophthalmic knifeof claim 7, wherein the bottom surface is planar.
 13. The ophthalmicknife of claim 7, further comprising a handle, wherein the lumen furtherterminates at an entry port in the handle.
 14. The ophthalmic knife ofclaim 7, wherein the lumen is configured to receive a viscoelastic fluidor an aspiration fluid.
 15. An ophthalmic knife, comprising: a shaft; aplatform connected to the shaft, the platform comprising a flat basehaving a proximal end connected to the shaft and a distal end oppositethe proximal end; and first and second blades that are separated by agap and extend from the distal end of the base to the shaft, whereinedges of the first and second blades are transverse to an edge of thedistal end.
 16. The ophthalmic knife of claim 15, wherein the first andsecond blades extend to the distal end of the base.
 17. The ophthalmicknife of claim 15, wherein the first and second blades, the base, andthe shaft surround a space containing the gap.
 18. The ophthalmic knifeof claim 15, wherein the edges of the first and second blades aresubstantially straight.
 19. The ophthalmic knife of claim 15, whereinthe edge of the distal end is substantially straight.
 20. The ophthalmicknife of claim 15, wherein each of the first and second blades definesan outer surface that extends continuously along a corresponding side ofthe shaft.